Pharmacovigilance and Regulatory Affairs

Global Harmonization of Regulatory Frameworks

The globalization of pharmaceutical markets has emphasized the urgent need for harmonized regulatory frameworks in pharmacovigilance. Disparate national regulations often lead to redundancies, inefficiencies, and gaps in drug safety monitoring. Efforts by international bodies such as ICH, WHO, EMA, and FDA are fostering convergence by standardizing terminologies (e.g., MedDRA), processes (e.g., ICH E2E), and reporting formats (e.g., E2B). Harmonization enables faster information exchange, uniform risk assessment, and consistent post-marketing surveillance across jurisdictions. It also facilitates regulatory reliance and work-sharing models, particularly benefiting resource-limited countries. However, challenges persist in aligning legal, cultural, and technological aspects across regions. Bridging these differences requires ongoing dialogue, capacity-building, and shared digital infrastructures. Ultimately, harmonized frameworks improve patient safety, accelerate regulatory decisions, and reduce the burden on industry while ensuring consistent pharmacovigilance practices worldwide.